Faecal Immunochemical Test (FIT) for Bowel Cancer Detection
High quality measurement of faecal haemoglobin for both asymptomatic and symptomatic assessment for bowel cancer and other colorectal diseases
FIT provides better analytical sensitivity and specificity for human haemoglobin and is superior in detection of adenomatous polyps as well as colorectal cancers (CRC).
Alpha Laboratories has many years experience in faecal haemoglobin testing having been involved with the UK Bowel Cancer Screening Programmes since 1998. Our solution for FIT testing is the HM-JACKarc system that offers fully automated testing and simple, hygienic sample collection for patients.
The HM-JACKarc is a high throughput, fully automated system that provides quantitative faecal haemoglobin concentration results on a simple to use platform.
It has a wide dynamic range from 7ng/ml to 400 ng/ml (ng/ml = µg Hb/g faeces), making it ideal for use in clinical settings for both asymptomatic screening and assessment of the symptomatic.
In recent years, some countries have replaced the traditional gFOBT strategy for screening with FIT (Faecal Immunochemical Tests for haemoglobin) since they provide better analytical sensitivity and specificity for human haemoglobin and are superior in detection of adenomatous polyps as well as colorectal cancers (CRC).
The use of FIT in the assessment of the symptomatic is changing too, as more publications have demonstrated that the use of quantitative FIT as a “rule-out” test has benefits to clinicians, laboratories and patients.
A recently accepted article, concluded that FIT is highly accurate for the detection of CRC in symptomatic patients and was more so than the NICE (National Institute for Health and Care Excellence) and SIGN (Scottish Intercollegiate Guidelines Network) referral criteria. This work demonstrated that, when FIT with a 20 µg Hb/g faeces cut-off concentration was used instead of the NICE referral criteria, 19.6% fewer colonoscopies would have been needed to detect 42% additional CRC.
Will your Laboratory FIT?
The new NICE guideline [NG12] published in June 2015, for “Suspected cancer: recognition and referral”, has recommended Faecal Occult Blood Testing (FOBT) as a cost effective method in primary care, for detecting colorectal cancers in people aged 40 or older with a change in bowel habit.
This new publication reverses the original decision from 2004, to cease guaiac based testing, which has resulted in a significant decline in FOBT since then.
Technological progress in FOBT has centred on Faecal Immunochemical Testing (FIT), which carries significant advantages over the original guaiac based test.
Quantitative FIT (qFIT) results have demonstrated greater sensitivity for cancers and high risk adenomas than guaiac and it is accepted that increasing detection levels of faecal haemoglobin (f-Hb) are indicative of increased risk of pathology 1,2.
Currently, there are many studies, published and in progress, that examine the usefulness of measuring faecal haemoglobin quantitatively in those presenting with symptoms. If useful in this setting, FIT could potentially reduce the burden of colonoscopy in a similar way to calprotectin testing, provided FIT were adopted as a routine test for the symptomatic.
The new guidelines now show that FIT is
...cost effective compared to colonoscopy and when assessed using the dominance rank method it becomes the most cost effective test."
This will stimulate a resurgence of requests for occult blood tests from primary care. Laboratories who embrace the newer technology of qFIT can provide a more proactive service to their community whilst embracing the productivity benefits of an automated system.
The HM-JACKarc system is easy to set up and can be loaded with up to 80 samples at any one time. It can stand alone or be linked to the LIS, allowing flexible options for connectivity and full audit trail of results, QC and reagent lot numbers.
Advanced Sample Collection System
Easy to use sample device collects a consistent sample size across different faecal matter
Internal septum removes excess sample
<2mg of sample in 2ml of buffer (ng/ml = µg Hb / g faeces)
Tamper seal and window to confirm sample applied
Unique bar code number for the tube (lot no./expiry date/tube no.
Collection buffer stabilises the faecal sample haemoglobin
• 120 days at 04°C (refrigerated)
• 14 days at 25°C (ambient temp)
Fully Automated Instrument
Compact and light bench top unit with touchscreen interface
Uses Integrated Sphere Latex Turbidimetry to measure faecal haemoglobin concentration
Sensitivity: 7 ng/mL
Cut-off concentrations can be selected depending on requirements – Screening or Symptomatic Testing
No prozone effect up to 200,000 ng/mL
High speed performance: 200 samples/hour
• Time to first result 5.6 minutes
• Additional results every 18 seconds
Factory set Master curve with local 2 point recalibration
• Calibrates system to local conditions and reagent combinations
• Calibration weekly
System can store 2 calibration curves
• Calibration of different lots of latex
• Same lots with different calibrators
Provides a large concentration of capture antibodies
Wide dynamic range 7ng/ml to 400 ng/ml (ng/ml = µg Hb/g faeces)
High Hook capacity > 200,000ng/ml Ensures no samples will give a falsely lower result
Drives reaction kinetics to end stage equilibrium quickly
3. A poster was presented by Ian Godber, Consultant Clinical Scientist, Clinical Lead, NHS Lanarkshire, at a workshop during the EuroLabFocus meeting in Liverpool on 8th October 2014.
This study was conducted at Monklands Hospital, where all patients undergoing a colonoscopy were asked to participate by providing a single small faecal sample, easily collected in a hygienic specimen collection device, for analysis on the HM-JACKarc system, before they underwent colonoscopy.
Download the Poster entitled; "Can an automated Faecal Immunochemical Test (FIT) determine whether faecal haemoglobin (f-Hb) concentrations can aid in stratifying symptomatic patients referred for colonoscopy".
Evaluates the HM-JACKarc for technical performance for specificity, sensitivity and precision across a range of different haemoglobin concentrations when stored in specific temperatures. Confirms the suitability of the system for the detection of haemoglobin in faecal samples
HM 2. Clinical Utility of HM-JACKarc for the Detection of Colorectal Cancer and High Risk Adenomas, JM AUGE Fradera et al., Laboratory of Biochemistry, School of Medicine, Hospital Clinic, Barcelona. Mar2014
Concludes that HM-JACK arc is easy to use and its’ analytical performance proves its suitability for use in clinical chemistry labs for early detection of colorectal cancer and high risk adenomas.
HM4. Studies on HM JACK for Fecal Occult Blood Analyser, Yutaka Nara, Noriko Harashima, Hitoshi Ikeda, Dept.of Laboratory Medicine, Saitama Medical Centre. The Saitima Journal of Medical technology 1999 vol. 46
The HM-JACK was shown to yield favourable intra and inter –day precision and accuracy,sufficient measurement range and stability of Hb after sampling.This analyser is fast and easy to use analysing 180 sample/hour.In addition ,stool sampling using piercing procedure yields good reproducibility making it a good choice for routine use.
HM5. Comparison of fecal occult blood assay by four companies. Sayuri Nakayasu et al, Division of Laboratory, Matsuai-kai, Matsuda Hospital
Compares the clinical sensitivity and specificity of reagents for Kyowa Medex ,Wako.Fujirebio and Azwell Co. Specificity comparison revealed that the kits of manufacturers using a high fecal concentration in the fecal sampler after sampling (i.e., final fecal concentration) tended to have a lower specificity. The important factors that impact on the sensitivity and specificity of the various kits are the determination of the cut-off value, the accuracy of fecal sampling and the characteristics of the antibody that is used.
HM 6. Evaluation of the Extel “Hemo Auto” HS and the Hemo Auto MC Feces Collection Container Using the HM-JACKarc Fully Automated Fecal Occult Human Hemoglobin Analyzer. Masahiro ITOH*1, Tsuyoshi FUKUDA*2, Go NAGAI*3 , Journal of Clinical Laboratory Instruments and Reagents, Vol. 34, No. 3 (June, 2011) – Supplement
An in house evaluation of HM-JACKarc covering specificity, sensitivity, prozone, sample stability etc.
Undetectable FIT is a good strategy to rule out ACRN. The diagnostic yield of 2 samples can be achieved with 1 sample but a lower cut off must be used.
Alpha Laboratories has been at the forefront of faecal testing in the UK for nearly 20 years. This was initially as the market leader for guaiac-based faecal occult blood testing in hospital laboratories. Tender wins for bowel screening in all four UK countries followed this, as each launched its own screening programme, assessing the average risk asymptomatic populations.
Continuing to provide leading edge products, Alpha Laboratories has been awarded the first contract for quantitative FIT as the front line test in the Scottish Bowel Screening Programme. This will employ the Kyowa Medex HM-JACKarc system. England will also be moving to a quantitative FIT method in the NHS Bowel Cancer Screening Programme in the near future, for which Alpha Laboratories was also successful in the tender for a framework agreement.